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Clinical Trials/EUCTR2016-001928-54-DK
EUCTR2016-001928-54-DK
Active, not recruiting
Phase 1

A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer

Bristol-Myers Squibb International Corporation0 sites489 target enrollmentJune 27, 2019
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DrugsYervoy (200mg/40ml)JEVTANA 60 mg concentrate and solvent for solution for infusionOpdivo (100 mg/10 ml)Opdivo (40 mg/4 ml)Yervoy (50mg/10ml)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
489
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 27, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- ECOG performance status 0\-1
  • •\- Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
  • •\- Ongoing androgen deprivation therapy (ADT) with a Gonadotropin\-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of \=1\.73nmol/L (50ng/dL).
  • •For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
  • •\- Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 154
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •\- Presence of visceral metastases in the liver
  • •\- Active brain metastases or leptomeningeal metastases
  • •\- Active, known, or suspected autoimmune disease or infection
  • •\- Prior treatment with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, or anti\-CTLA\-4 antibody, or any other antibody or drug specifically targeting T\-cell co\-stimulation or checkpoint pathways.
  • •For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
  • •\- Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab.
  • •\- Have received systemic anti\-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel).

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code: 10036909Term: Prostate cancer metastatic Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10076506Term: Castration-resistant prostate cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
CTIS2022-502909-15-00477
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Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2016-001928-54-DEBristol-Myers Squibb International Corporation489
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A Study to Evaluate Preliminary Efficacy of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer
EUCTR2016-001928-54-ESBristol-Myers Squibb International Corporation495
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Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men, with Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2016-001928-54-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO497
Active, not recruiting
Phase 1
Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer
EUCTR2016-001928-54-PLBristol-Myers Squibb International Corporation489